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Intranasal Dexmedetomidine for Pain Relief During Retinopathy of Prematurity Screening in Preterm Infants <30 Weeks Gestation Using Standard Drug Combination

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Retinopathy of prematurity is a condition that can affect the eyes of babies born very early, potentially leading to vision problems. During routine eye examinations, several eye‑drop medicines are used to widen the pupil and numb the eye, including oxybuprocaine, phenylephrine and cyclopentolate. In this study a single dose of dexmedetomidine given through the nose, or a matching sodium chloride solution (placebo), is added to the usual eye‑drop regimen before the exam.

The aim is to find out whether the nasal dose of the study drug reduces the pain measured by the Premature Infant Pain Profile‑Revised during the first 30 seconds after the eye speculum is placed. Infants are randomly assigned to receive either the study drug or the placebo, then undergo the standard eye screening while pain scores and basic vital signs are recorded. After the exam the infants continue to be observed for a short period to monitor any breathing changes, oxygen needs, crying, sleep, or other reactions before returning to regular care.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial registration and randomisation
After you agree to join the study, basic information such as weight and gestational age is recorded.
You are assigned to receive either intranasal dexmedetomidine or a placebo (0.3 ml sodium chloride solution) without knowing which one.
Step 2
Pre‑exam eye‑drop preparation
The care team prepares three eye‑drop solutions that are part of standard care:
oxibuprokain eye drops (1.2 mg per dose),
phenylephrine eye drops (150 µg per dose), and
cyclopentolate eye drops (150 µg per dose).
Each drop is applied to the infant’s eyes according to the protocol before the screening exam.
Step 3
Administration of the study medication
Once the eye drops are in place, the assigned study medication is given intranasally.
If you are in the active group, the dose is dexmedetomidine 2 µg per kilogram of body weight delivered as a nasal spray.
If you are in the placebo group, you receive 0.3 ml of sodium chloride solution intranasally.
The medication is given once for each screening session.
Step 4
Screening eye examination and pain monitoring
The ophthalmologist performs the retinopathy of prematurity screening using a speculum.
Pain is assessed during the first 30 seconds after the speculum is inserted using the premature infant pain profile‑revised (pipp‑r) score.
Additional observations such as heart rate, respiratory rate, oxygen saturation, and any cardiorespiratory events are recorded.
Step 5
Post‑exam observation and follow‑up
After the speculum is removed, pain is assessed again with the pipp‑r score.
The infant is observed for at least one hour to monitor heart rate, breathing, oxygen needs, cry duration, sleep time, vomiting episodes, and any changes in respiratory support.
All observations are entered into the study database.

Who can join the trial?

1 criterion

Infants born early (before 30 weeks of pregnancy, known as gestational age <30 weeks) who will have the regular eye exam for retinopathy of prematurity (ROP) screening and whose parents have signed the permission form for the study.

Who cannot join the trial?

12 criteria

Received any medication for sedation or pain (except sugar water) within the last 24 hours before the eye exam; this includes pharmacological sedation/analgesia.
Has a severe brain bleed called intraventricular hemorrhage that is classified as grade 3‑4.
Has abnormal brain development, known as cerebral malformations.
Has a heart problem present from birth, referred to as congenital heart disease.
Has an irregular heartbeat, known as arrhythmia.
Is currently on a breathing machine (mechanical ventilation) or needs medication to keep blood pressure up (vasopressor) at the time of the exam.
Has any nose shape or blockage that could interfere with giving the medicine through the nose (nasal anatomical abnormalities).
Is allergic or has a strong reaction to dexmedetomidine or any of its inactive ingredients (excipients).
Has low blood pressure that is not being controlled (uncontrolled hypotension).
Has a recent serious brain blood‑vessel problem (acute cerebrovascular condition) that is not already listed above.
Has a slow heart rate (bradycardia) that is not caused by a temporary issue like a breathing pause.
Has very poor liver function, described as severe hepatic impairment.

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Verified sites

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Helse Stavanger HF
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Stavanger, Norway
St. Olavs Hospital HF
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Trondheim, Norway

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Investigated drugs

Oxybuprocaine eye drops
are a local anesthetic that is applied to the surface of the eye. In the trial they are used to numb the eye before the retinopathy of prematurity screening, helping to make the eye exam more comfortable for the baby.
Phenylephrine eye drops
are a medication that makes the pupil of the eye larger. In the study they are given before the eye exam so the doctor can see the retina more clearly during the screening.
Cyclopentolate eye drops
also cause the pupil to widen and relax the eye’s focusing muscles. They are used together with other eye drops to keep the pupil open for a clear view of the retina during the screening procedure.
Dexmedetomidine
is a medication that can calm and reduce pain. In this trial it is given through the nose (intranasally) to preterm infants before the eye screening, with the goal of lowering the pain they feel compared to the standard care alone.

What is already known about the treatment

Oxybuprocaine
This medication is given as eye drops in a liquid solution and is applied directly onto the surface of the eye. It is an established local anesthetic that is commonly used for short‑term pain relief during eye examinations and minor procedures. It works by temporarily blocking sodium channels in the nerves of the eye, which stops pain signals from being sent to the brain. It belongs to the class of ester‑type local anesthetics.
Phenylephrine
Phenylephrine is administered as eye drops in a clear solution that is placed in the eye to widen the pupil. It is a well‑known drug used to dilate pupils for eye examinations and surgeries. The drug stimulates alpha‑1 adrenergic receptors in the eye’s muscles, causing them to contract and the pupil to enlarge. It is classified as an alpha‑adrenergic agonist.
Cyclopentolate
This drug is provided as eye drops in a liquid form and is applied to the eye to both dilate the pupil and temporarily paralyze the eye’s focusing muscle. It is routinely used in pediatric eye exams and other diagnostic procedures. Cyclopentolate blocks muscarinic receptors, which prevents the eye’s muscles from responding to nerve signals. It falls under the class of anticholinergic cycloplegic agents.
Dexmedetomidine
Dexmedetomidine is given as a solution for infusion that can be administered intranasally, allowing the medication to be absorbed through the nasal lining. It is an approved sedative and pain‑relieving drug used in intensive‑care settings and is being studied to reduce discomfort during eye‑screening procedures. The drug selectively activates alpha‑2 adrenergic receptors in the brain, lowering norepinephrine release and producing calmness and reduced pain perception. It is classified as an alpha‑2 agonist sedative.
Sodium chloride
Sodium chloride is supplied as a sterile 0.9 % solution for injection that can be given intranasally as a placebo. It is a standard electrolyte solution used worldwide as a diluent or vehicle for other drugs, with no specific therapeutic effect on its own. The solution simply provides a harmless fluid that mimics the administration route of the active drug. It is categorized as a normal saline solution and a diluting agent.

Investigated diseases

Retinopathy of prematurity - Retinopathy of prematurity is an eye condition that affects babies born very early. It begins when the small blood vessels in the retina grow irregularly. Over weeks, these vessels may leak fluid or form scar tissue that can pull on the retina. The disease can move from mild, harmless changes to more extensive abnormal vessel growth. Watching the retina over time shows how the condition progresses.